The Islamic perception of the socio-economic process is dynamic and its insistence on social justice is uncompromising. To produce the best social structure, according to this view, man’s economic endeavours should be motivated by a meaningful moral philosophy. In the face of the challenges...
Published May 7th 2013 by Routledge
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for...
Published June 5th 2012 by CRC Press
Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses...
Published February 15th 2011 by CRC Press
A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries
One of the most common reasons so many new drug, medical device, or equipment applications are rejected each year by the FDA is the failure to properly develop and document plans and procedures. This is required of both U.S. and foreign companies wishing to market their products in the United...
Published December 11th 2010 by CRC Press
Handbook of Transition with CD-ROM
Environmental Management System ISO 14001:2004 provides the information and practical know-how required to facilitate a smooth adoption and incorporation of the latest revisions and enhancements put forth by the International Organization for Standardization. This unique work shows how to adopt or...
Published October 28th 2010 by CRC Press
A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries
During the past decades, enormous progress and enhancement of pharmaceutical manufacturing equipment and its use have been made. And while there are support documents, books, articles, and online resources available on the principles of cleaning and associated processing techniques, none of them...
Published May 23rd 2010 by CRC Press
A Comprehensive Training Guide for the Biotechnology Industry
All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology:...
Published April 12th 2009 by CRC Press
A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, 2nd Edition
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production....
Published May 29th 2006 by CRC Press
The Ultimate Guide to FDA, GMP, and GLP Compliance
The Master Validation Plan provides a roadmap to management for on-time start-up of facility operations, and validation of existing facilities, in compliance with GMP requirements. The lack of a comprehensive Master Validation Plan and well-documented validation procedures is the main reason that...
Published December 26th 2001 by CRC Press
2000 Document Development Compliance Manual: A Complete Guide and CD-ROM
Don't reinvent the wheel when applying for your ISO 9001 registration or updating to the new 2000 standards. ISO 9001:2000 Document Development Compliance Manual: A Complete Guide and CD-ROM shows you how to develop and implement a documented quality management system based on ISO 9000 series...
Published June 26th 2001 by CRC Press